133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T+64 4 496 2000
3 November 2021
M.R.M.
By email:
[email address]
[email address]
[FYI request #17264 email]
Ref:
H202114662
Tēnā koe M.R.M.
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) on 19 October
2021. Your requests have been consolidated under section 18(A) of the Act.
1. Has Medsafe approved the safety and efficacy of Novovax vaccines? If not, what
progress has been made in this area, and, when is this likely to happen?
2. What are the delivery timeframes of Novovax vaccines currently?
3. Has consideration been given to the use of Novavax vaccines in New Zealand, and if
so what decision has been reached and the reasons for that.
4. Has a decision been reached not to use Novovax vaccines in New Zealand, and if so
what are the reasons for that.
5. Has a decision been reached not to use Novovax vaccines in New Zealand, and what
are the consequences of agreeing to purchase 10.72 mil ion doses ... in particular wil
there be penalties payable for breaching the agreement by withdrawing from or cancelling
the agreement?
This vaccine is not currently approved for use in New Zealand. Medsafe is New Zealand’s
medicines safety authority and it robustly assess all vaccines to ensure they meet international
standards and local requirements for quality and safety. If you would like to check the approval
of any COVID-19 vaccines in New Zealand, you can do so on Medsafe's website here:
https://www.medsafe.govt.nz/COVID-19/status-of-applications.asp.
As noted on the website, Medsafe is currently assessing the application for the Novavax
vaccine with some data under evaluation and further data to be provided by the sponsor. We
recommend that you continue checking the link above for further updates.
Once approved, Cabinet then considers advice and makes decisions on when and for who a
particular vaccine wil be used as part of the COVID-19 immunisation programme. If or when
Cabinet approves a 'decision for use', this would determine how the Novavax vaccine would be
used in New Zealand. If the Novavax vaccine is regulated for use by Medsafe, and Government
decides to use this vaccine in New Zealand, we expect Novavax delivery in early 2022.
6. Noting that it was also disclosed that New Zealand has bought enough vaccines for the
Cook Islands, Niue, Tokelau, Sāmoa, Tonga, and Tuvalu, and if a decision has been
reached not to use Novovax vaccines in New Zealand, wil the abovementioned
agreement be honoured by the New Zealand government through providing one or more
of the aforementioned countries with Novovax vaccines, and, if so what are the reasons
for that?
New Zealand has purchased a portfolio of COVID-19 vaccines from four suppliers: Pfizer,
AstraZeneca, Janssen, and Novavax. New Zealand has offered access to our vaccine portfolio
for the Realm nations and territories (Cook Islands, Niue and Tokelau) and Sāmoa, Tonga and
Tuvalu. The Realm nations and territories and Samoa and Tonga have requested Pfizer
vaccines. While a request for the Novavax vaccine has not been received, there is still the
option for countries to request alternative vaccines from other donors to complement their
existing roll out plan. New Zealand of icials are working closely with their counterparts in these
nations to understand the support they need from New Zealand and will respond
accordingly. As noted above, Novavax has started to submit an application to Medsafe for its
COVID-19 vaccine. Medsafe is reviewing the data and is waiting for further information from the
company. For further updates you can refer to this page:
https://www.medsafe.govt.nz/COVID-
19/status-of-applications.asp.
7. What is the cost to New Zealand of buying enough vaccines for the Cook Islands, Niue,
Tokelau, Sâmoa, Tonga, and Tuvalu? Please provide the fullest possible answer with cost
breakdowns and giving me complete disclosure of financial estimates, actual costings,
etc.
New Zealand has earmarked $65 mil ion in Official Development Assistance in vaccine access
and rollout, ensuring enough vaccines and support can be provided to cover the Realm and
Polynesia and; and ensuring support to other countries in the Pacific with access to vaccines
along with Australia and other partners in the region. Your request for cost breakdowns is
refused under section 9(2)(j) of the Act, to enable a Minister or any public service agency to
carry on negotiations without prejudice or disadvantage (including commercial and industrial
negotiations).
8. Why is New Zealand responsible for buying vaccines for the Cook Islands, Niue,
Tokelau, Sâmoa, Tonga, and Tuvalu when our health workers have had a 3 year
moratorium placed on salary increases, the cost of living in New Zealand is robbing
people of their hard-earned income and leaving many families hungry, and, - in my
opinion - we need to take care of our own before we take care of anyone else? Again,
please provide the fullest possible answer with cost breakdowns and giving me complete
disclosure of financial estimates, actual costings, etc.
New Zealand is best placed to support these countries directly because of our constitutional
relationships and the especially strong links between our health systems, our close people-to-
people ties and builds on the technical support New Zealand has provided throughout the
pandemic.
The Cook Islands, Niue and Tokelau are constituent parts of the Realm of New Zealand, with
the Cook Islands and Niue being self-governing in free association with New Zealand. All
residents of the Realm are New Zealand citizens. New Zealand has a Treaty of Friendship with
Samoa which requires the New Zealand Government to “consider sympathetically requests from
the Government of … Samoa for technical, administrative and other assistance.” The Treaty is
publicly available at:
www.treaties.mfat.govt.nz/search/details/t/609.
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if Novovax wil not be made available as aforementioned, then wil it be possible for those
who want it as a first and second dose Covid-19 vaccination to self-fund this treatment? If
not, why not,, and, what would the likely cost of it be per vial if this is to be an option?
As advised above, a decision regarding Novavax is stil being assessed. Medsafe approval is
one step in the process for accessing a COVID-19 vaccine. Once approved, Cabinet then
considers advice and makes decisions on when and for who a particular vaccine wil be used as
part of the COVID-19 immunisation programme. If or when Cabinet approves a 'decision for
use', this would determine how the Novavax vaccine would be used in New Zealand.
I want to know what caused such a radical change as to bring the Government to recently
decide it is now mandatory that teachers and workers in the health and disability sectors
be fully vaccinated as a condition of their employment (when most if not al of the
Individual and Collective Employment Agreements in New Zealand do not require this as
an health and safety related employment term and condition).
can you please advise me which law or laws in New Zealand compel people to undergo
Covid-19 treatment to address a public health issue but which recognizes and upholds the
right to consent or not to such treatment?
what is the Government's position in relation to the punitive measure for non-compliance
which has and wil continue to see workers being fired from their jobs for simply exercising
their Bil of Rights Act endorsed right not to receive medical treatment by declining to have
a Covid-19 vaccination?
The Health Act 1956 provides for situations where persons may be directed to undertake health
treatment or otherwise be subject to restrictions when they have, or are believed to have, a
notifiable disease such as COVID-19. In addition, Orders made under the COVID-19 Public
Health Response Act 2020, such as the COVID-19 Public Health Response (Vaccinations)
Order 2021, may require persons to undergo vaccination or other medical treatment relating to
COVID-19.
Al Orders made, including the COVID-19 Public Health Response (Vaccinations) Order 2021,
are made with regard to the New Zealand Bil of Rights Act 1990 (NZBORA). Under NZBORA,
rights may be subject to such reasonable limits prescribed by law as can be demonstrably
justified in a free and democratic society, such as supporting requirements for vaccination
where this is necessary for public health.
1. On what date did the Pfizer Covid-19 and the BioNTech vaccine clinical trials end?
2. If the Pfizer Covid-19 and the BioNTech vaccine clinical trials have not yet ended, on
what date wil they end, or, on what date wil they likely end?
3. If the Pfizer Covid-19 and the BioNTech vaccine clinical trials have not yet ended, did
Pharmac nonetheless approve their use in New Zealand, and if so under what conditions
did this happen?
Pfizer clinical trial data can be found on their website here:
https:/ www.pfizerclinicaltrials.com/find-a-trial?search=Coronavirus,COVID-
19&distance=1000&age=7.
4. If the Pfizer Covid-19 and the BioNTech vaccine clinical trials have not yet ended, this
would mean that they are stil in the experimental phase of development. In such
circumstances, and with the Government having taken on the liability of claims that may
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arise from use of the Pfizer and BioNTech vaccines, what laws, regulations, rules,
guidelines etc. make it the responsibility of the Accident Compensation Corporation to
accept cover of injuries that are in all probability caused by vaccines that have a) not been
fully and properly trialed and b) are stil in the experimental phase of development?
The vaccine is not experimental. It has been granted provisional consent under section 23 of
the Medicines Act 1981. Please refer to the approval process page on the Medsafe website
above.
Please note that on 28 October 2021 Medsafe renewed the provisional consent for the Pfizer
Comirnaty COVID-19 vaccine. Al conditions that have been met to date have been removed
from the renewed consent. For more information s
ee www.medsafe.govt.nz/COVID-19/status-
of-applications.asp. Medsafe also issued a media release on this:
www.health.govt.nz/news-
media/news-items/medsafe-renews-covid-19-vaccine-provisional-approval.
It is not unusual for companies to run clinical trials for approved vaccines. There are lots of
approved medicines that have ongoing trials for new indications.
In any case, any treatment harm caused by COVID-19 vaccination is covered by Accident
Compensation Corporation if the criteria are met. There is more information
at:
www.acc.co.nz/covid-19/providers/general-covid-19-provider-information.
New Zealand operates a no-fault accident compensation system, there is no requirement to
indemnify employers and/or healthcare providers. ACC provides assistance and cover in these
situations:
www.covid.immune.org.nz/faq/will-acc-provide-cover-covid-19-vaccination-injuries.
I trust this fulfils your request. Under section 28(3) of the Act, you have the right to ask the
Ombudsman to review any decisions made under this request. The Ombudsman may be
contacted by email at:
[email address] or by calling 0800 802 602.
Please note that this response, with your personal details removed, may be published on the
Ministry website at:
www.health.govt.nz/about-ministry/information-releases.
Nāku noa, nā
Nick Allan
Manager, OIA Services
Office of The Director General
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